India, June 2 -- Aragen, a leading global Contract Research, Development, and Manufacturing Organisation (CRDMO), has successfully tech-transferred and manufactured the first commercial-scale GMP batches of Renaissance Pharma's lead candidate, Daretabart - a humanised monoclonal antibody (mAb) targeting GD2 for high-risk neuroblastoma - in just 9 months.

The anti-GD2 monoclonal antibody received Fast Track Designation from the FDA in April 2026 for the treatment of high-risk neuroblastoma (HRNB), a rare pediatric cancer. This milestone builds on a broader strategic partnership between the two companies, with Aragen having developed the cell line and initial process at its Morgan Hill site in California. GMP manufacturing for the programm...